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StrokePhase 1/2NCT01453829

Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells in Patients After Stroke

A Phase 1/2 study testing Harvesting and Isolation of Stem Cells in people with Stroke, run by Ageless Regenerative Institute at 1 site in Mexico.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The intent of this clinical study is to answer the questions: 1. Is the proposed treatment safe 2. Is treatment effective in improving the disease pathology of patients after Stroke and clinical outcomes? Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Stroke
What is being tested?
Harvesting and Isolation of Stem Cells
How many people
0 participants
Where
1 siteMexico
Study dates
Oct 2014to Jun 2015
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males and Females between Age 18 and 80 years.
  • Symptoms and signs of clinically definite ischemic stroke or hemorrhagic stroke
  • DWI-MRI has reliably shown relevant ischemic lesions
  • Extracranial duplex/transcranial Doppler must confirm intra/extracranial arteries permeability
  • The stroke is severe (NIH Stroke Scale >= 8 before procedure)
  • Up to date on all age and gender appropriate cancer screening per American Cancer Society.

Who cannot join

  • Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
  • Life expectancy < 6 months due to concomitant illnesses.
  • Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
  • Active infectious disease and/or known to have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis will have expert consultation to determine eligibility based on the patient's infectious status
  • Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
  • Patients on chronic immunosuppressive transplant therapy
Show all 12Show fewer
  • Systolic blood pressure (supine) ≤90 mmHg or greater than 180mmHg
  • Resting heart rate > 100 bpm;
  • Active clinical infection being treated by antibiotics within one week of enrollment.
  • Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
  • History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
  • Unwilling and/or not able to give written informed consent.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Hospital Angeles

    Tijuana, Estado de Baja California, 22010

Other trials in Mexico

About this study

Official title: An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Into the Internal Carotid Artery and Intravenously in Patients After Stroke

The intent of this clinical study is to answer the questions:

  1. Is the proposed treatment safe
  2. Is treatment effective in improving the disease pathology of patients after Stroke and clinical outcomes?
Read the detailed description

Adipose-Derived Stromal Cells (ASCs) are a novel therapy for patients suffering from stroke. By injecting ASCs either into the internal carotid artery, these regions may become populated with the ASCs, thereby potentially restoring brain function. ASCs are a patient-derived ("autologous") cell transplantation technology that is delivered to the patient into the internal carotid artery and intravenously. The therapy is composed of cells derived from a patients' own adipose tissue that are isolated within approximately 1 hour and immediately delivered back to the patient.

Conditions
Stroke
Being tested
Harvesting and Isolation of Stem Cells
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Harvesting and Isolation of Stem CellsProcedure or surgery

    This will be an open-label, non-randomized multi-center patient sponsored study of ASC implantation using a catheter delivery system. ASCs will be derived from the patient's adipose-derived tissue. Liposuction using local anesthesia and syringe collection will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells. The cells will be implanted into the Internal Carotid Artery and intravenously.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvement in clinical function from baseline as assessed by the NIH stroke scale at three months

    Measured: 3 months

  2. Number of participants with adverse events

    The safety of adipose-derived stem cell injection will be evaluated by assessment of the frequency and nature of adverse events occurring during the study injection and up to the 6-month period following treatment.

    Measured: 1 week

  3. Number of participants with adverse events at 2 weeks

    Measured: two weeks

  4. Number of participants with adverse events at 4 weeks

    Measured: 4 weeks

  5. Improvement in clinical function from baseline as assessed by the NIH stroke at 6 months

    Measured: 6 months

  6. Number of participants with adverse events at 3 weeks

    Measured: 3 weeks

  7. Improvement in clinical function as assessed by Barthel Scale compared to baseline at 6 months

    Measured: 6 months

Secondary outcomes (6)

  1. Improvement in clinical function as assessed by Modified Rankin Score compared to baseline at 3 months

    Measured: 3 months

  2. Improvement in clinical function as assessed by Barthel Scale compared to baseline at 3 months

    Measured: 3 months

  3. Improvement in Magnetic resonance imaging (MRI) scan compared to baseline at three months

    Measured: 3 months

  4. Improvement in clinical function as assessed by Modified Rankin Score compared to baseline at 6 months

    Measured: 6 months

  5. Improvement in clinical function as assessed by Barthel Scale compared to baseline at 6 months

    Measured: 6 months

  6. Improvement in Magnetic resonance imaging (MRI) scan compared to baseline at six months

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2011 (estimated)
  2. Study startOct 2014
  3. Primary completionDec 2014 (estimated)
  4. Study completionJun 2015 (estimated)

Why it stopped: no enrolled participants

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01453829
Sponsor's protocol ID
ADI-ST-ME-001
Status last verified
Jul 2017
First submitted
3 Oct 2011
Last updated
21 Jul 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Harvesting and Isolation of Stem Cells in people with Stroke, run by Ageless Regenerative Institute at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement in clinical function from baseline as assessed by the NIH stroke scale at three months (time frame: 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01453829.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.

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